Glenmark Pharma gets USFDA nod for Acetaminophen and Ibuprofen tablets
The regulatory authority has determined these tabletes as bioequivalent to Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings.
The regulatory authority has determined these tabletes as bioequivalent to Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings.
Lifesciences slipped nearly 3 per cent to Rs 933.40 on BSE after the pharma firm said USFDA had concluded the inspection of its plant with 10 observations.
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner, Zydus Lifesciences said.
The USFDA sought a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, discrepancies, failure, and records management system.
Natco Pharma on Tuesday said it has received a warning letter from the US health regulator for its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) had issued eight observations under Form 483 after inspecting the company's Kothur-based formulation facility.
The tentative approval by the US Food & Drug Administration (USFDA) was for Ribociclib tablets of strength 200 mg, Alembic Pharmaceuticals said in a regulatory filing.
Noland Arbaugh, the 29-year-old patient who was paralyzed below the shoulder after a diving accident, was playing chess on his laptop and moving the cursor using the Neuralink device.
Aripiprazole Tablets USP are indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder and treatment of tourette’s disorder.
Sun Pharma is recalling approximately 55,000 bottles of a generic medication used to treat bowel disease in the US market. The recall is due to "Failed Dissolution Specifications," according to the US Food & Drug Administration (USFDA). The affected Mesalamine extended-release capsules were manufactured at Sun Pharma's Mohali plant and distributed in the US by Sun Pharmaceutical Industries Inc. Mesalamine capsules are indicated for treating mild to moderate ulcerative colitis. The US generic drug market was valued at around USD 115.2 billion in 2019, with Sun Pharma being a major player in the market.
Demand has been far outpacing supply with some analysts forecasting the market for weight-loss drugs, currently led by Novo Nordisk's Wegovy and Eli Lilly's Zepbound and Mounjaro, could reach $100 billion a year by the end of the decade.
Orchid Pharma on Friday said it has received approval from the US health regulator to market a medication used to treat patients with complicated urinary tract infection. The drug firm has received new drug approval from the US Food and Drug Administration (USFDA) for Enmetazobactam, Orchid Pharma said in a statement.